The U.S. Food and Drug Administration’s (“FDA”) is responsible for the regulation and oversight of the U.S. OTC drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC drug products into the U.S. Under this current regulatory regime, there are 3 pathways that a company may follow to enter the OTC drug market including (a) following an appropriate Drug Monograph; (b) with an Agency approved New Drug Application (“NDA”); or (c) via the currently popular Rx-to-OTC Switch Process.

This course on FDA regulation of OTC drug products is intended to provide attendees with the knowledge and skills needed to develop and produce an OTC Drug Product for marketing and sale in the U.S. Attendees will gain an understanding of :

  • Various available options for producing and selling an OTC drug product,
  • U.S. Food and Drug Administration’s (“FDA”) regulation of OTC drug products,
  • Strategic recommendations for mitigating the risk of enforcement action in the future.
Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Participants who attend this course on FDA regulation of OTC drugs will:

  • Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S.
  • Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
  • Recognize the difference between the various pathways for commercializing an OTC Drug Product.
  • Understand how to identify and successfully navigate an OTC Drug Monograph.
  • Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
  • Understand how to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC Drug and understand the difference between Category I, II and II Ingredient designations.
  • Identify the required elements of a compliant OTC Drug Label.
  • Take away strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.
  • Possess a working knowledge of the Rx-to-OTC Switch Process.
  • Review and evaluate several of FDA's current OTC Monographs
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Day 01(8:30 AM - 4:30 PM)
  • Registration Process - (8:30 am till 9:00 am)
  • Session Start Time: 9:00 AM
  • Lecture 1: Overview of Drug Regulation in the United States
    • Role and function of FDA generally
      • FDA’s purpose and mission
      • FDA’s jurisdiction
      • FDA’s six “product centers”
        • Center for Food Safety and Applied Nutrition (CFSAN)
        • Center for Drug Evaluation and Research (CDER)
        • Center for Biologics Evaluation and Research (CBER)
        • Center for Devices and Radiological Health (CDRH)
        • Center for Tobacco Products
        • Center for Veterinary Medicine (CVM)
      • FDA’s operation
    • Structure of FDA: Specifics of CDER
      • CDER’s mission
      • CDER’s jurisdiction
      • CDER’s organization (discuss divisions and duties within each office)
    • Introduction to the FDCA, Regulations, and Guidance Documents
      • Overview of FDCA and regulations
      • Introduction to FDA guidance
  • Lecture 2: OTC drugs v. Rx Drugs
    • Differences between the two
    • How to distinguish
  • Lecture 3: History of Regulation of OTC Drugs in the US
    • Statutory and Regulatory Authority for OTC Drugs
      • 1938: Federal Food Drug Cosmetic Act (FFDCA) drug safety requirement.
      • 1951: Durham-Humphrey Amendments to Federal Food, Drug and Cosmetic Act (FFDCA) designated drugs that cannot be used safely without professional supervision as prescription drugs and all other drugs as OTC.
      • In order for an OTC drug active ingredient to be included in an OTC monograph it must have been marked prior to May 11, 1972.
      • Two legal pathways for OTC drug marketing post 1938.
      • Marketing in compliance with drug monograph
      • Marketing under the authority of an approved New drug application (NDA).
  • Lecture 4: OTC Drug Review Process
    • New Drug Approval Process
      • NDA
        • Rare for a company to pursue an approved NDA for a non-prescription drug because of the expense and effort involved with obtaining FDA approval.
      • Rx-to-OTC
        • The Rx-to-OTC Switch regulatory pathway is becoming increasingly popular as companies look for ways to extend the life cycle of their branded prescription products but similar to the option above, an Rx-to-OTC Switch requires FDA’s approval of an NDA.
    • OTC Drug Monograph System
      • Developed in the 1970’s in response to a whole class of marketed non-prescription drug products that existed in the market that had never been reviewed for safety and effectiveness.
      • Attempt to “clean up” the market
      • Development of the monograph process (or “OTC Drug Review”)
      • OTC drugs as Generally Recognized as Safe & Effective (“GRAS&E”).
  • Lecture 5: OTC Drug Monographs
    • Process
      • Notice of Proposed Monograph
      • Proposed Final Monograph
      • Final Monograph
    • Final OTC monograph establishes the acceptable:
      • active ingredients
      • concentration of the active ingredients
      • therapeutic claims
      • indications
      • labeling/warning requirements
      • directions for use
    • Marketing the OTC drug product when the Monograph is not final
  • Lecture 6: Policy Reasons Behind the Monograph Process
  • Day 02(8:30 AM - 4:30 PM)
    • Lecture 7: Status of specific OTC Monographs, their included Regulatory Requirements and Strategies for Commercialization
      • Antimicrobial
      • Cold & Cough
      • External Analgesic
      • Internal Analgesic
      • Laxatives
      • Nasal Decongestant
      • Skinning Bleaching
      • Skin Protectants
      • Sunscreens
      • Other Monographs as appropriate
    • Lecture 8: OTC Drug Ingredients
      • Substantiating the safety and efficacy of a proposed new ingredient
      • Showing why an Ingredient should be included in the Monograph
      • The concept of GRAS
    • Lecture 9: Marketing a drug product that deviates from a final monograph
      • Suitability Petitions
    • Lecture 10: OTC Drug Labels, Labeling, Marketing and Advertising Issues
      • An OTC product's indications are limited to (a) those approved by FDA in the case of an OTC application or an Rx to OTC Switch product, or (b) the uses and indications included in the relevant monograph.
        • Beyond those indications, other labeled uses and indications are not permitted.
      • Definitions of the terms “label” and “labeling”
      • Labeling includes the Immediate Container, Outer Packaging, Package Insert, Client Information Sheet, Shipping Label
      • Elements of an OTC Drug compliant label
        • Active Ingredient
        • Use
        • Warnings
        • Inactive Ingredients
        • Purpose
        • Directions
        • Other Information
      • Promotional Materials
        • Brochures, Press Releases, Flyers, Audio and Advertising
        • Written Media, Broadcast Media, Internet Media, Social Media
      • Strategies for Regulatory Compliance
    • Lecture 11: FDA Enforcement Actions
      • Noncompliance and Enforcement
        • FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution
          • FDA’s Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy
        • Local, State, and Tribal governments
        • Types of Enforcement Actions
          • Warning Letters and Untitled Letters
          • Seizures
          • Injunctions
          • Monetary Penalties (21 USC §§ 303 and 307)
          • Criminal Prosecution
          • Debarment
        • Park Doctrine – Corporate Official Liability under FDCA
        • Overlapping Agency Jurisdiction – FDA, DOJ, FTC, USDA, and State Agencies
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    Loren Gelber

    Loren Gelber
    Regulatory Compliance Consultant (Ex-FDA Official)

    Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.

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